When a drug switches from being prescription-only to over-the-counter (OTC), it’s generally a cause for celebration – at least among folks who take the medicine. That’s because OTC drugs are, generally speaking, easier to get and cheaper to buy.
Over the last couple of decades, hundreds of prescription drugs once available only with a doctor’s recommendation have switched to OTC. The list contains many familiar names: Children’s Advil (ibuprofen) and Aleve (naproxen sodium) for pain relief and fever reduction; Pepcid AC (famotidine) and Prilosec OTC (omeprazole magnesium) for heartburn; Rogaine (minoxidil) for hair growth; Claritin (loratadine) for allergies; and Nicorette gum (nicotine polacrilex) for smoking cessation.
How does a drug morph from prescription to OTC? We’re talking about healthcare so, not surprisingly, it’s a bit complicated but basically the process begins with a few different reasons:
- The prescription drug treats an ailment that’s easy to self-diagnose. Most folks know when they need something for a bout of the flu or a flaring seasonal allergy. You can’t say that about more complex condition like cancer or heart disease, which require medical expertise.
- The prescription drug has a solid history as an effective and popular medication, reducing concerns that it might pose health risks with greater use.
- The prescription drug’s patent is about to expire.
- The drug is easy to use, hard to abuse.
OTC drugs generally target short-term conditions with easily recognized symptoms, such as a headache or runny nose. Chronic conditions, such as high blood pressure or diabetes, are more problematic. The problem with making drugs relevant to these conditions OTC is that it would require patients to understand complex aspects of their disease and its treatment. That’s hard to do and helps explain why a hugely popular prescription drug like atorvastatin (Lipitor) and other statins are not likely to become OTC anytime soon.
Before 1951, there was no clear-cut distinction between prescription and OTC drugs. Then the law was amended to require that drugs that can’t be used safely without professional supervision be dispensed only by prescription. These drugs tend to be habit-forming or toxic, have a great potential for harmful effects or treat medical conditions that can’t be readily self-diagnosed.
By law, all other drugs can be sold OTC. Indeed, a drug must be made available without prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance.
The actual path from prescription to OTC typically happens one of two ways:
- During an OTC drug review, which are on-going assessments of the safety and effectiveness of all nonprescription drugs. These are conducted by panels of nongovernmental experts.
- The drug manufacturer submits a supplemental application to the Food and Drug Administration for a change in status, providing new data indicating an already approved product is appropriate for OTC. The
Food and Drug Administration (FDA) reviews the evidence, consults experts and makes a ruling. The vast majority of so-called Rx-to-OTC switches occur this way. Before approving a switch, the FDA weighs several considerations. Among them:
- What’s the benefit-to-risk ratio? No drug is 100 percent safe, so does the promised health benefit of wider, easier access to a drug outweigh its potential harm. There’s no set formula for making this assessment. Sometimes the FDA will approve a new OTC drug, but require that it be sold at lower doses than prescription counterparts.
- Is the drug easy to label? For most consumers, the specifics of an OTC drug are reduced to what it says on its label and box. These bits of text must include intended uses, directions and warnings. They must be understandable by people of differing backgrounds and educations. The FDA requires that drug labels be clear and truthful. If that’s too hard to do for a wannabe OTC drug, it won’t become an OTC drug.
It’s important to remember that while a drug is sold OTC, it’s still a drug. There are guidelines to using it safely and effectively. These should always be followed. Since 2005, OTC drugs have had standardized labeling to make it easier for people to understand the directions and use them safely. The pipeline of future OTC drugs is never empty, though it’s difficult to predict which specific medications will next achieve OTC distinction.
Even the makers of statins continue to push for OTC status. So far, the FDA has rebuffed the idea, in large part because taking a drug that lowers cholesterol levels requires the consumer to actively understand and monitor their levels of lipids or fats in the blood.
Right now, that’s hard for the ordinary consumer to do at home, but drug makers are developing possible ways to address the issue with self-serve kiosks, touchscreen pads and interactive videos.
Any conversation about OTC drugs should include at least a nod to the related topic of
dietary supplements, which racked $32 billion in sales in 2012.
The industry includes the purveyors of everything from vitamins, minerals like calcium and potassium, amino acids (the individual building blocks of protein), herbs like
and St. John’s Wort or parts of these substances.
Consumers use dietary supplements for everything from boosting their nutrient intake to easing insomnia to addressing a diverse array of diseases and conditions.
But unlike OTC medications, which undergo a rigorous approval process because they will ultimately be used without medical supervision, dietary supplements fall under the
Dietary Supplement Health and Education Act of 1994, which does not mandate nearly the same degree of federal oversight and regulation.
“Dietary supplements cannot make any claims to diagnose or treat a condition, which is why the labels usually say ‘may help with…,’” said Sarah McBane, PharmD, associate clinical professor in the
Skaggs School of Pharmacy and Pharmaceutical Sciences at UC San Diego. “They are not regulated by the FDA. No FDA approval is required prior to marketing. Manufacturers are responsible for labeling, contents, etc. Advertising of these is regulated by the
Federal Trade Commission. Supplements carry no guarantees of purity, potency or efficacy.”